Co-Diagnostics印度合资公司启动结核病PCR检测临床研究

PCR Pro Instruments and MTB Test Kits Now Deployed to Select Labs Across India
SALT LAKE CITY, July 22, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that CoSara Diagnostics Pvt. Ltd. ("CoSara"), the Company's joint venture in India, is initiating clinical studies for the tuberculosis test on the CoSara PCR Pro® instrument.
The initiation of these clinical studies marks another critical milestone for the Co-Dx PCR platform*, following the Company's previously announced shipment of PCR Pro instruments, mycobacterium tuberculosis ("TB" or "MTB") test kits and proprietary sample preparation instruments to CoSara. The decentralized point-of-care platform leverages patented Co-Primers® technology to deliver rapid, gold-standard real-time PCR results in roughly 30 minutes via a mobile application.
The CoSara PCR Pro instrument, the CoSara-branded version of the Co-Dx™ PCR Pro point-of-care instrument, is currently being deployed in select labs across India for TB testing evaluation. Co-Dx PCR platform products, including PCR test kits and the sample lysis instrument, are expected to be manufactured and distributed in India under the CoSara brand.
India accounts for a significant share of the global tuberculosis burden, making it one of the most strategically important markets for the Company's mission of closing critical gaps in access to high-quality PCR testing, especially in decentralized settings.
*The Co-Dx PCR platform (including the PCR Home®, PCR Pro®, mobile app, and all associated tests) is subject to review or authorization by applicable regulatory authorities in the jurisdictions in which clearance or approval is sought, including the US FDA, and is not yet available for sale.
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform (subject to regulatory review and not currently for sale) and to identify genetic markers for use in applications other than infectious disease.
About CoSara Diagnostics Private Limited:
CoSara Diagnostics Private Limited is an India-based molecular diagnostics company formed as a joint venture between Co-Diagnostics, Inc. and Synbiotics Ltd, a subsidiary of Ambalal Sarabhai Enterprises Ltd. (ASE Group), a continuation of one of the oldest and most respected Indian manufacturing institutions in operation today. CoSara was established in 2017 to manufacture and commercialize molecular diagnostic instruments and assays in India, leveraging Co-Diagnostics' proprietary PCR technology platform while operating under applicable Indian regulatory frameworks. The company is focused on expanding access to high-quality, affordable PCR-based diagnostic solutions for use in India and other permitted markets.
Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will," "seeks," "anticipates," and similar expressions, or the negative of these terms. Forward-looking statements in this press release include, but are not limited to, statements regarding the conduct, timing, completion and results of clinical studies evaluating the CoSara MTB assay and CoSara PCR Pro instrument; the performance, reliability, speed and potential uses of the Co-Dx PCR platform; the Company's and CoSara's plans regarding regulatory submissions, reviews and authorizations; the potential manufacture, distribution and commercialization of Co-Dx PCR platform products in India and other markets; the anticipated role of distribution and other commercial partners; and the potential for the platform to expand access to PCR-based testing.. Such statements are subject to a number of risks and uncertainties, including, without limitation: risks that market demand or public health conditions may change; risks related to the Company or its joint venture's ability to successfully complete a clinical study for a TB test in India; risks related to the Company' or its joint venture's ability to commercialize the platform in a strategically important market, including risks that distribution partners may not successfully market, promote, or sell the Company's products; risks associated with international operations, including changing regulatory requirements, economic conditions, reimbursement environments, import/export restrictions, and foreign currency fluctuations; risks related to regulatory review by regulatory authorities that would be required to achieve a successful commercial launch; risks related to the performance, reliability, and market acceptance of the Co-Dx PCR platform and other Co-Dx technology; risks associated with dependence on third parties, suppliers, collaborators, and distribution partners; risks related to competition, technological change, and intellectual property protection; and other risks described from time to time in the Company's filings with the Securities and Exchange Commission ("SEC"). Actual results may differ materially from those expressed or implied in these forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements. A further description of risks and uncertainties can be found in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2026, and in its other filings with the SEC. The Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
SOURCE Co-Diagnostics